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Assessment of Poliovirus Type 2 Immunogenicity of One and Two Dose Schedule With IPV and fIPV When Administered at 9-13 Months of Age in Bangladesh

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ClinicalTrials.gov Identifier: NCT03890497
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : April 10, 2020
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Brief Summary:

Following a recommendation on October 2017 meeting of the Strategic Advisory Group of Experts (SAGE) on Immunization; low- risk bOPV-using countries may adopt 2 dose fIPV schedule prior to global OPV cessation as it provides better seroconversion than 1 full dose IPV and in the post-cessation era, the 2 fIPV doses will provide sufficient (above 90%) seroconversion. Countries, which delayed the introduction of IPV or had a vaccine stock-out, should provide 1 full dose or 2 fIPV doses to all children who were missed as soon as supply becomes available. The IPV supply situation is expected to improve in 2018; all countries are expected to have access to IPV for their routine immunization programmes from the end of the first quarter of 2018.

While immunogenicity after one and two doses of IPV and fIPV has been estimated when administered to younger children ; the immunogenicity of IPV (or fIPV) when administered at 9 months of age or later is not known. We propose to conduct a study to assess the immunogenicity of one and two doses of fIPV and IPV when administered between 9-13 months of age.


Condition or disease Intervention/treatment Phase
Poliomyelitis Biological: IPV Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: • To assess the seroconversion to PV2 after one and two doses of fIPV and IPV when first dose is administered to children aged between 9 and 13 months with second dose administered 2 months later.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Assessment of Poliovirus Type 2 Immunogenicity of One and Two Dose Schedule With IPV and fIPV
Actual Study Start Date : September 27, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

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Arm Intervention/treatment
Active Comparator: Full dose of IPV
IPV first dose between 9 -13 months with second dose administered 2 months later.
Biological: IPV
The inactivated poliovirus vaccine (IPV) developed by Salk was the first available polio vaccine licensed in 1955 in the United States. The current formulation of IPV got licensed in 1987 and has a higher potency than the original Salk IPV. Almost 100% of children two months of age or older who receive 2-3 doses of intramuscular (IM) IPV achieve high antibody levels against the all three serotypes. IPV (.5mL) can be administered subcutaneously (SC) or IM and fractional (0.1 ml) doses of IPV are generally administered intradermally
Other Name: fIPV

Active Comparator: Fractional Dose of IPV
fIPV first dose between 9 -13 months with second dose administered 2 months later
Biological: IPV
The inactivated poliovirus vaccine (IPV) developed by Salk was the first available polio vaccine licensed in 1955 in the United States. The current formulation of IPV got licensed in 1987 and has a higher potency than the original Salk IPV. Almost 100% of children two months of age or older who receive 2-3 doses of intramuscular (IM) IPV achieve high antibody levels against the all three serotypes. IPV (.5mL) can be administered subcutaneously (SC) or IM and fractional (0.1 ml) doses of IPV are generally administered intradermally
Other Name: fIPV




Primary Outcome Measures :
  1. Seroconversion to PV2 two months after the first fIPV or IPV dose [ Time Frame: 2 months ]


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Ages Eligible for Study:   9 Months to 13 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Apparently healthy children with no obvious clinical symptom of illness
  2. Parents/legal guardians of participants willing to give written informed consent and willing to comply with study protocol.
  3. Free of obvious health problems (congenital abnormalities, severe malnutrition, acute or chronic diarrhea, bleeding disorder etc) as established by medical history and screening evaluation including clinical examination.
  4. Resident of study area.

Exclusion Criteria:

  1. Participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination or planned participation in another clinical trial during the present trial period.
  2. A diagnosis or suspicion of congenital or acquired immunodeficiency disorder, malignancy,
  3. A diagnosis or suspicion of bleeding disorder
  4. Acute or persistent diarrhoea
  5. History of allergy or systemic hypersensitivity to any of the vaccine components
  6. Chronic illness at a stage that could interfere with trial conduct or completion.
  7. Presence of significant malnutrition
  8. History of any neurological disorder or history of seizure (febrile or afebrile), or encephalopathy, encephalitis, hypotonic-hyporesponsive episode.

09. Febrile illness or acute illness on the day of inclusion

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890497


Contacts
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Contact: Asma Aziz, MBBS, MPH +8801719326323 ext 3812 asma.aziz@icddrb.org

Locations
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Bangladesh
Matlab Health Research Centre Recruiting
Chandpur, Bangladesh
Contact: Asma Aziz, MBBS, MPH    +8801719326323 ext 3812    asma.aziz@icddrb.org   
Mirpur Study clinic Recruiting
Dhaka, Bangladesh
Contact: Asma Aziz, MBBS,MPH    +8801719326323 ext 3812    asma.aziz@icddrb.org   
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
World Health Organization
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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT03890497    
Other Study ID Numbers: PR- 18016
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Poliomyelitis
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases